The Life Science Career Network
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Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a:
PVQA (Pharmacovigilance and Quality Assurance) Manager
for a 12 months-contract based in the area of Basel.
- Providing expertise and supporting Pharmacovigilance unit;
- Representing PVQA for Pharmacovigilance System;
- Supporting the company, the suppliers and vendor teams (e.g. GDS, GMA, Marketing, affiliate) in staying compliant with regulatory requirements (e.g. answering questions; participating to meeting to discuss PV issues);
- Qualifying PV vendors;
- Completing PSMF part under responsibility of PVQA;
- Escalating serious or continuing non-compliance PV issues as appropriate/necessary;
- Providing support with trainings on PV requirements;
- Contributing to PV process improvements (e.g. via audit finding / CAPA) and PV electronic systems (e.g. Testing Quality Event Module);
- Managing PV deviation as per Deviation QS documents;
- Facilitating the PV inspections and CAPAs elaboration, approval and follow-up PVQA Audit;
- Planning, performing, and reporting standards GVP audits (e.g. affiliate, supplier, process, studies).
Qualifications and Experience:
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- At least a bachelor degree or equivalent education/degree in sciences or healthcare;
- At least 3 years of experience within pharmaceutical industry/health authorities working in Pharmacovigilance field;
- Good knowledge of GVP regulatory requirements and pharmaceutical industry practices;
- Experience in GxP quality systems, compliance monitoring, CAPA management, and/or the development and maintenance of standards and training programs;
- Being an Auditor.
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